FDA 483 - Dexcom, Inc. - November 07, 2024

An FDA inspection of Dexcom, Inc. in San Diego, CA, a manufacturer of continuous glucose monitoring systems, revealed significant deficiencies across its quality system. Observations included inadequate procedures for process parameter monitoring, validation of test systems, and design controls for both G6 and G7 CGM systems. The firm also failed to adequately establish procedures for design changes, risk analysis, and corrective and preventive actions, raising concerns about product quality and patient safety.